Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

Postoperative Pain Clinical Trial

Official title:

Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696095
• Other study ID #: 2018-000822-70
• Status: Completed
• Phase: Phase 4
• Start date: April 16, 2018
• Est. completion date: December 6, 2018

Study information

• Verified date: January 2019
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

Description:

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 6, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• admitted for unilateral primary total knee arthroplasty.

Exclusion Criteria:

• ASA score > 3

• BMI > 40

• refusal of loco-regional technique.

• psychiatric disease.

• inability to understand/ use the Local anesthetic delivery pump.

• local anesthetic allergy,

• porphyry,

• uncontrolled epilepsy,

• severe cardiac arrhythmia.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Complications
• Postoperative Pain

Intervention

Drug:
• Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
programmed intermittent bolus 5ml each one hour.
• Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
continuous infusion 6ml/h

Locations

Country	Name	City	State
Belgium	CHU Liege	Liège

Sponsors (1)

Lead Sponsor	Collaborator
J P Lecoq

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of unplanned analgesia interventions.	Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.	up to 72 hours after surgery
Secondary	Pain difference	Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.	up to 72 hours after surgery
Secondary	Motor block frequency	Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.	up to 72 hours after surgery
Secondary	Mobilization quality during physiotherapy sessions.	accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee).	up to 72 hours after surgery
Secondary	local anesthesia technique related complications	rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.	until catheter removal 48 hours after surgery